Issues concerning 'wonder drug'

Dr. C.V. Krishnaswami, Head of the Diabetes Department, Voluntary Health Services (VHS), Chennai, writes:

On July 1, The Hindu published a news item `City institute to take part in diabetes prevention project' (Chennai city edition Page 3). It raised some important questions relating to the ethical and medical aspects of drug intervention studies in the prevention of a symptomatic impaired glucose tolerance stage of diabetes and the need to monitor these by an independent body of experts, familiar with our people. `The National Academy of Medical Sciences' (which is a constitutionally-created apex body of medical scientists) is one such. My viewpoint was published unabridged by The Hindu on July 5, under the title `The wonder drug that wasn't' (Page 11). In my write-up I had not mentioned the names of any person or institution.

After a gestation of three weeks, Dr. V. Mohan, Director, Madras Diabetes Research Foundation, Chennai, and Dr. Salim Yusuf, Director, Division of Cardiology, and Dr. Hertzel Gerstein, Director, Division of Endocrinology, McMaster University, Hamilton, Canada, presented their viewpoint ``to set the record straight''. This was published in The Hindu on July 26 (Page 13), where my name was repeatedly mentioned. I do not wish to enter into an argument, at any personal or institutional level, on what has been said by them. But the three writers have not answered any of the following points:

(1) The medico-moral issue of using chemical compounds on a long- term basis for a long number of years on symptom-free individuals with borderline glucose tolerance (IGT) test abnormality in laboratory tests; (2) Drugs that have been in clinical use on patients for about three years in a study spanning for more than six years; (3) The medical wisdom in the choice of the drugs; (4) The use of statistics to create panic in the minds of the public is to be abhorred. I had quoted a study where 5.5 per cent IGT cases became diabetic in the one-year study period, and also noted that 64.3 per cent of the same group which had IGT became normal and 30.2 per cent remained status quo, during the same period. To extend this number unilaterally to the diabetes conversion alone with simple arithmetical jugglery is not scientific and contrary to medical statistical principles; (5) There is a need for an autonomous statutory national committee of experts - e.g., the ethics committee of the National Academy of Medical Sciences - to clear such drug trials affecting the lives of a large number of people; and (6) and the funding agencies involved and their competing interests.

I have been in clinical practice of diabetes, research and education for three-and-a-half decade and fully support progressive initiatives in clinical research in diabetes. At the same time, the medical profession should bear in mind the oath of Hippocrates that we should do no harm to patients by our actions.

I would leave it to the medical intelligentsia and the enlightened readers of The Hindu to decide whether the points raised by me have been answered by the three medical men. Generally, people live on, because of the hope and dreams, and sometimes in spite of them!

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